Exposure to diverse agents, such as ionizing radiation, excessive use of oxygen during strenuous physical activities, exhaust fumes, solvents and dust particles produces excessive amounts of free radicals. The extent of production of these free radicals depends, at least in part, upon the dose and type of the agents to which one is exposed. Free radicals are known to cause damage to various organs. Damaged organs initiate inflammatory reactions, the products of which (such as pro-inflammatory cytokines, reactive oxygen species, adhesion molecules, complement proteins and prostaglandin E2) are very injurious to the cells. Taken together, the condition of excess free radicals and the damage caused thereby is often referred to as, “oxidative stress”.
It is well documented that increased oxidative stress and acute or chronic inflammation are major etiological factors in the initiation and/or the progression of various diseases, such as diabetes, heart disease, Alzheimer's disease and AIDS. They have also been shown to be connected with the aging process.
The present invention is, therefore, based on the finding that antioxidants at appropriate dosages and an appropriate dose schedule can neutralize free radicals, as well as reduce inflammation; therefore, they can be helpful in ameliorating a variety of adverse health conditions, as well as against exposure to several injurious agents.
Some unpublished studies on the role of antioxidants in reducing the risk of human diseases have utilized single antioxidants, primarily vitamin E or beta-carotene in high-risk populations such as heavy cigarette smokers. The results demonstrated that the risk of lung cancer and the markers of heart disease actually increased. These results could have been predicted, however, prior to the commencement of these experimental studies. This is due to the well-established fact that the individual antioxidants, when oxidized, act as free radicals. Heavy cigarette smokers have a high internal oxidative environment; therefore, beta-carotene or vitamin E will be oxidized in this environment and will act as a pro-oxidant, rather than as an antioxidant. It has been found, however that the same vitamin, when present in a multiple vitamin preparation, will not be oxidized under the same environmental conditions, because other antioxidants will act to reduce its oxidation effect. There are no data, moreover, which show that beta-carotene or vitamin E, when present in a multiple vitamin preparation containing dietary and endogenous antioxidants, produced any adverse effects on humans.
Currently, i.e., in the period prior to the development of the present invention, the appropriate combination(s) and dosages of antioxidants offering the greatest benefit to human health are not well established. Nevertheless, increasing numbers of people are taking some form of supplement in the hope that it will serve to optimize their health. Unfortunately, at present, they rely for advice upon health-related magazines, books, advertising, radio and television reports and/or vitamin store salespeople. As a result, most people consume these nutrients without any scientific rationale. Furthermore, the majority of vitamin/mineral preparations have not given adequate attention to the dose, type and chemical form of the antioxidants they ingest, or with regard to appropriate minerals and other micronutrients typically found in admixtures of antioxidant formulations.
One particular, but by no means the only, class of individuals displaying a demonstrated need for supplementing their diet with appropriate antioxidants and micronutrients, includes individuals who are veterans of military service. Such individuals are prone to long-term adverse effects of environmental and physical stressors, and toxic chemicals, typically encountered during training and/or during combat operations.
There has thus been a long-felt need by healthy individuals of both sexes from a variety of age groups for a nutritional supplement engineered to provide optimal health, taking into account their age and sex, as well as by military veterans seeking to undo acute and/or chronic damage produced by free radicals and products of inflammatory reactions that are generated by the environmental and physical stressors, and toxic chemicals to which such individuals are routinely exposed. The methods and formulations according to the present invention have thus been designed with these requirements in mind.